Medical device recalls Moderate risk

Madison Polymeric Engineering recalls First Step Draco Pad, Product Number EP-4D

Recall date
May 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1925-2019
FDA classification
Class II
Brand / firm
Madison Polymeric Engineering
Sold / distributed
The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.

Why it was recalled

This product has been contaminated with Stenotrophomonas lactiubi.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

First Step Draco Pad, Product Number EP-4D

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